United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 4 mg in 4 ml - topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (sclc) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of patients with stage iv-b, recurrent, or persistent cervical cancer not amenable to curative treatment. topotecan hydrochloride is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions (6.2)] . risk summary based on animal data and its mechanism of action, topotecan hydrochloride can cause fetal harm when administered to a pregnant woman. there are no ava

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 1 mg in 1 ml - topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy. topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan injection in combination with cisplatin is indicated for the treatment of patients with stage iv-b, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. risk summary based on animal data, topotecan can cause fetal harm when administered to a pregnant woman. topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose [see data]. there are

Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - topotecan hydrochloride equivalent to topotecan - concentrate for soln for inf - 1 mg/ml - other antineoplastic agents

Canada - English - Health Canada

sandoz canada incorporated - topotecan (topotecan hydrochloride) - solution - 1mg - topotecan (topotecan hydrochloride) 1mg - antineoplastic agents

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - topotecan hydrochloride - solution for infusion - 1mg/1ml

Israel - English - Ministry of Health

novartis israel ltd - topotecan as hydrochloride - powder for solution for infusion - topotecan as hydrochloride 4 mg/vial - topotecan - topotecan - topotecan monotherapy is indicated for the treatment of:• patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.• patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate.topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage ivb disease.patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - topotecan hydrochloride - powder for solution for infusion - 1mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

actavis uk ltd - topotecan hydrochloride - powder for solution for infusion - 4mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord healthcare ltd - topotecan hydrochloride - solution for infusion - 1mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

accord healthcare ltd - topotecan hydrochloride - powder for solution for infusion - 4mg